Kornimate/medical-research-clean huggingface dataset:
group therapy for caregivers of alzheimer's disease patients in spanish elderly persons centres

Conditions: Alzheimer's Disease

Summary: an experimental study designed to test the effectiveness of a psychological intervention based on group therapy for the caregivers of alzheimer's disease patients. the intervention consists of 16 sessions of a cognitive-behavioral psychological group therapy. this study aims to demonstrate that alzheimer's patients' caregivers can decrease the feelings of burden after been involved in a group therapy.


Eligibility criteria:
inclusion criteria: * main caregiver of an alzheimer disease patient. * alzheimer disease patient with mild/severe cognitive impairment. * high compliance to therapy sessions. * sign informed consent. exclusion criteria: * low commitment to develop all study phases. * caregiver activity remunerated. * caregiver with psychiatric disorders that can affect the development of the sessions. * caregivers who have received psychological care during last year.

Keywords: family caregivers psychotherapy group
fractal analysis of the pulmonary arterial tree in pulmonary hypertension

Conditions: Pulmonary Hypertension

Summary: the investigators propose to confirm that normotensive and hypertensive pulmonary arteries are fractal, as well as define if the fd correlates to disease severity when compared to available data such as six-minute walk and right heart catheterization measurements.

pulmonary hypertension (ph) is an insidious disorder that can occur in isolation or as a result of various other pulmonary and systemic conditions. if left untreated ph may progress to right heart failure and death. numerous tests are suggestive but not diagnostic of ph including cardiac echo, pulmonary function testing and chest x-ray. definitive diagnosis requires right heart catheterization that is invasive, costly and time consuming. the fractal dimension (fd) is an index of the space-filling properties of an object so that the closer the dimension is to the topological dimension in which the object is embedded, the greater the space filling properties. no investigations have been performed to analyze the fractal dimension of pulmonary arteries in patients with ph. we propose to confirm that normotensive and hypertensive pulmonary arteries are fractal, as well as define if the fd correlates to disease severity when compared to available data such as six-minute walk and right heart catheterization measurements.

Eligibility criteria:
inclusion criteria: * patients having a right heart catheterization and ct pulmonary angiogram exclusion criteria: * none

Keywords: pulmonary hypertension fractal dimension
efficiency of xal-ease device in glaucoma and/or ocular hypertension (oht) patients, treated with xalatan or xalacom

Conditions: Glaucoma; Hypertension

Summary: xal-ease is a novel pfizer-pharmacia device aimed to significantly facilitate the xalatan/xalacom instillation and to avoid loss of xalatan/xalacom eye drops due to incorrect instillation. patients on xalatan/xalacom who have consumed more than one bottle per month within a year according to consumption data drawn from the clalit health services database, will use the xal-ease device for a year. the device is expected to reduce consumption of bottles and result in saving money for both patients and medical care providers.


Eligibility criteria:
inclusion criteria: * patients with glaucoma or hypertension treated with xalatan/xalacom who have consumed more than one bottle per month within a year prior to initiation of the study. exclusion criteria: * patients younger than 18 years, * patients with severe manual disabilities, * patients with impaired cognition and mentality.

Keywords: drug consumption the xal-ease device patient's compliance using a novel pfizer-pharmacia device to facilitate the xalatan/xalacom instillation and to avoid loss of eye drops
basophile activation testing (bat) in hazelnut allergy (hazelnut bat study)

Conditions: Food Allergy

Summary: the proposed study intends to compare the outcome of food challenge in hazelnut allergic patients with the outcome of basophile activation tests using hazelnut extract and components.

accurate diagnosis of food allergy depends on food challenge outcome. the proposed study intends to compare the outcome of food challenge in hazelnut allergic patients with the outcome of basophile activation tests using hazelnut extract and components to evaluate the diagnostic utility of basophile activation testing. with a view towards improved in vitro diagnostic methods, the investigators intend to evaluate the diagnostic potential of basophile activation testing in patients with hazelnut allergy confirmed by a positive provocation or supported by a convincing history of anaphylactic reaction(s) to hazelnut in the past, patients with pollinosis but no symptoms of hazelnut allergy and non-atopic control subjects.

Eligibility criteria:
inclusion criteria: primary inclusion criteria: * male and female subjects, age ≥ 14 years * informed consent as documented by signature secondary inclusion criterion * group a: positive case history of allergic reaction(s) to hazelnut positive double-blind placebo-controlled food challenge with hazelnut or positive titrated open food challenge with hazelnut or unambiguous case history of an anaphylactic reaction after hazelnut will be included without provocation * group b:positive skin test (spt) with birch pollen and hazelnut and negative food provocation with hazelnut. * group c: negative case history of hazelnut and birch allergy and negative skin test (spt) with hazelnut and birch pollen and negative food provocation with hazelnut exclusion criteria: * drugs not allowed due to interference with the food challenge (or shortest interval between last treatment and food challenge): corticosteroids systemically (2 weeks), antihistamines (3 days), beta blocker (1 day), angiotensin converting enzyme (ace) inhibitors (2 days), omalizumab (2 months) * women who are pregnant * lack of safe contraception * uncontrolled asthma, forced expiratory volume (1 second) \<70% predicted value * acute allergic disease * chronic urticaria * mastocytosis * other clinically significant concomitant disease states * known or suspected non-compliance, drug or alcohol abuse, * inability to follow the procedures of the study * participation in another study with investigational drug within the 30 days preceding and during the present study

Keywords: hazelnut allergens basophile-activation-test food allergy
a demonstration project to add pre- or post-exposure prophylaxis to combination hiv prevention services

Conditions: HIV Prevention

Summary: the purpose of this study is to evaluate the safety, acceptability and feasibility of delivery of pre-exposure prophylaxis (prep) or post-exposure prophylaxis) pep as part of combination hiv prevention services for high-risk msm and transgender women.

two community-based sites (lalgbt center and the oasis clinic) will serve as facilities at which participants may present for screening for prevention services. at the sites, eligibility criteria will be assessed, hiv, sexually transmitted disease (std) and laboratory testing will be performed, and hiv prevention service referrals will be initiated. follow-up will be on a monthly basis for the first three months, and then de-escalated to an every-3-month interval. the program stratifies participants into two cohorts on the basis of sexual risk behavior: a low-moderate risk cohort (lm) and a high-risk cohort (h). participants in the lm cohort will be provided a customized prevention package (cpp) including access to pep for emergency hiv prevention in the event of unanticipated hiv exposure. participants in the h cohort will be provided a cpp including daily truvada-based prep. all participants will be followed for 48 weeks. participants in the lm cohort who, on longitudinal sexual risk behavior surveillance, report increased levels of sexual risk-taking such that they meet enrollment criteria for the h-cohort will be transitioned to the h-cohort. at each follow-up visit, a careful safety assessment will be made, including signs/symptoms and laboratory assessments. std testing will be performed at 3 month intervals. an escalating-intensity adherence intervention will be implemented based on real-time plasma tenofovir levels. a computer-assisted self-interview (casi) will be used to capture detailed sexual risk, adherence, and substance use behavior.

Eligibility criteria:
inclusion criteria: * at least 18 years of age * able to understand and provide consent in english or spanish * self identified msm, msm/w, or transfemale * at least one male sex partner for anal intercourse in the prior 12 months * hiv negative by enzyme immunoassay (eia) and viral load (vl) * crcl ≥ 60 ml/min (via cockcroft-gault formula) * no signs or symptoms suggestive of primary hiv infection (phi). exclusion criteria: * participants \<18 years of age * unable to understand and provide consent in english or spanish * known or found on testing to be hiv positive * any condition, which in the opinion of the intake provider, will seriously compromise the participant's ability to comply with the protocol, including adherence to pep or prep medication dosing * use of antiretroviral therapy (art) taken for any indication (i.e. pep or prep) within 60 days of study entry * previous participation in an hiv vaccine trial. participants that were documented to have received only placebo are not excluded. * signs or symptoms suspicious for phi.
a study to evaluate treatment of hepatitis c virus infection in pediatric subjects

Conditions: Chronic Hepatitis C Infection

Summary: this was a phase 2/3, open-label, multicenter study to evaluate the pharmacokinetics (pk), efficacy, and safety of ombitasvir/paritaprevir/ritonavir (obv/ptv/rtv) with or without dasabuvir (dsv) and with or without ribavirin (rbv) in hepatitis c virus (hcv) genotype 1 or 4 (gt1 or gt4)-infected pediatric participants of ≥ 3 to 17 years of age.

the study population for part 1, the pk study, included gt1-infected participants who were noncirrhotic and treatment-naïve (tn). part 2, the safety and efficacy study, included gt1 or gt4-infected participants who were tn or interferon (\[ifn\] or pegylated-interferon alfa-2a or 2b \[pegifn\] with or without rbv) treatment-experienced (te) without cirrhosis or with compensated cirrhosis. in part 1 and part 2, the treatment regimen and duration were dependent on hcv gt, gt1 subtype, and cirrhosis status.

Eligibility criteria:
inclusion criteria: 1. positive anti-hepatitis c virus antibody (hcv ab) and hcv ribonucleic acid (rna) ≥ 1000 iu/ml at the time of screening 2. hcv genotype 1 for enrollment into part 1 of the study and genotype 1 or 4 for enrollment into part 2 3. parent or legal guardian with the willingness and ability to provide written informed consent and participant willing and able to give assent, as appropriate for age and country exclusion criteria: 1. female participant who is pregnant, breastfeeding or is considering becoming pregnant 2. use of known strong inducers and inhibitors (e.g., gemfibrozil) of cytochrome p450 2c8 (cyp2c8) in participants receiving dasabuvir, or strong or moderate inducers of cyp3a, within 2 weeks or 10 half-lives, whichever is longer, of the respective medication/supplement prior to study drug administration. 3. positive test result for hepatitis b surface antigen (hbsag) or anti-human immunodeficiency virus antibody (hiv ab) test 4. current enrollment in another interventional clinical study, previous enrollment in this study, prior or current use of any investigational or commercially available anti-hcv agents other than interferons or ribavirin or receipt of any investigational product within 6 weeks prior to study drug administration

Keywords: hepatitis c virus hepatitis c genotype 1 hepatitis c genotype 4 pediatric
targeting the optimal mean arterial pressure in hypoxic ischemic brain injury after cardiac arrest

Conditions: Cardiac Arrest

Summary: hypoxic ischemic brain injury (hibi) is the ensuing brain injury after cardiac arrest and is the primary cause of adverse outcome. hibi is caused by low oxygen delivery to the brain. the patient's blood pressure is primary determinant of oxygen delivery to the brain. international guidelines recommend maintaining uniform blood pressure targets in all patients, however, this 'one size fits all approach' fails to account for individual baseline differences between patient's blood pressures and extent of underlying disease. recently, 'autoregulation monitoring', a novel brain monitoring technique, has emerged as a viable tool to identify patient specific blood pressures after brain injury. this personalized medicine approach of targeting patient specific blood pressure (mapopt) is associated with improved outcome in traumatic brain injury. it has not been evaluated in hibi after cardiac arrest. recently, i completed a first-in-human study demonstrating the ability to identify mapopt in hibi patients using neuromonitoring (microcatheters inserted into the brain tissue). the proposed study in this grant is to take the next step and investigate the changes in key brain physiologic variables (brain blood flow and oxygenation) before and after therapeutically targeting mapopt in hibi patients. this interventional study will serve as the basis to embark on a pilot randomized control trial of mapopt targeted therapy versus standard of care in hibi patients after cardiac arrest.


Eligibility criteria:
inclusion criteria: * we will include any patient 19 years or older who are admitted to the icu following cardiac arrest with a post-resuscitation glasgow coma scale of 8 or less. * existing arterial line in situ as part of their clinical care. * enrolled within 72 hours of their cardiac arrest * patients must have had more than 20 consecutive minutes of spontaneous circulation following resuscitation * duration of cardiac arrest greater than 10 minutes prior to return of spontaneous circulation. this is to ensure that we will not be placing intra-parenchymal bolts in patients who are likely to have a favourable neurological outcome regardless of monitoring. exclusion criteria: 1. coagulopathy (inr \> 1.5, ptt \> 40, platelets \< 100) 2. cardiac catheterization procedure is anticipated within the next 7 days. 3. current or anticipated use of anticoagulant or antiplatelet medication. importantly, subcutaneous heparin or dalteparin for deep venous thrombosis prophylaxis may be used provided it is not administered 12 hours prior to insertion or removal of the bolt. this practice is currently utilized in our tbi population. 4. undergoing therapeutic hypothermia with a target temperature under 35oc. 5. known or prior history of severe tbi, intracranial hemorrhage or stroke that would interfere with cerebral oximetry (i.e. significant prior damage to the frontal lobes). 6. no current commitment to ongoing support by the medical team 7. acute st elevation myocardial infarction -
the efficacy and safety of nab-paclitaxel plus s-1 in first-line treatment of advanced biliary tract adenocarcinoma

Conditions: Biliary Tract Cancer

Summary: advanced biliary tract adenocarcinoma has a poor prognosis with limited therapeutic options. nab-paclitaxel plus s-1 chemotherapy will be given to untreated patients with advanced biliary tract adenocarcinoma for the first-line treatment.

gemcitabine/nab-paclitaxel has become a standard therapy in advanced pancreatic cancer. given the morphologic and histologic similarities between pancreatic cancer and biliary tract adenocarcinoma, nab-paclitaxel may be a promising regimen, and s-1 has been approved for biliary tract cancer in japan. untreated patients with advanced biliary tract adenocarcinoma will receive nab-paclitaxel 120 mg/m2 (d1, d8, q3w) and s-1 (40mg bid for body surface area\ 1.5 m2; d1-14, q3w) as the first-line treatment. the investigators will investigate the efficacy and safety of the combination treatment, and expect to provide a more effective treatment plan for patients with advanced biliary tract cancer in china.the primary endpoint is objective response rate(orr), and the secondary endpoints are progression-free survival(pfs), overall survival(os) and the safety.

Eligibility criteria:
inclusion criteria: * age, years: 18-70 * histologically and cytologically confirmed advanced biliary tract adenocarcinoma, unresectable, measurable lesions according to recist criteria; ecog score of 0-1; life expectancy ≥12 weeks; * untreated; more than 6 months after the last adjuvant chemotherapy (does not include taxanes and s1); * laboratory examination within 14 days before entering the study should meet following requirements: anc ≥ 1.5 x 10\^9/l; plt ≥ 100 x 10\^9/l; hb ≥ 90g/l (9g/dl); ast, alt ≤ 2.5 x uln (with no liver metastasis), ≤ 5 x uln（with liver metastasis); creatinine ≤ 1.5 x uln; tbil ≤ 1.5 x uln * both male and female subjects of potential fertility have to agree effective birth control during the entire study * informed consent exclusion criteria: * concurrent other effective treatment (including radiotherapy) * resectable patients * allergy history to other drugs in the same class patients with pregnancy or lactation * known severe internal medical diseases * abnormal heart function or relevant history of myocardial infarction and severe arrhythmia * immunocompromised patients, such as hiv positive * uncontrollable mental illness * other conditions the researchers considered ineligible for the study

Keywords: nab-paclitaxel, s-1, advanced biliary tract adenocarcinoma
metabolites profiling reveals nutrient processing patterns upon dietary loading

Conditions: Metabolism Disorder; Nutrition

Summary: the reasonable combination of macronutrients including carbohydrates, proteins and fat, is the basis of rational diet and beneficial to treatment of metabolic diseases including obesity and diabetes. endocrine hormones play pivotal roles in regulation of nutrients metabolism and energy homeostasis. however, the dynamic metabolism following the consumption of macronutrients and the relationship between various metabolites and endocrine hormones during these procedures yet to be adequately explained nowadays. therefore, in this study, the investigators selected glucose, protein, fat and mixed meal tolerance test (mmtt) for the loading tests, endocrine hormones and metabolites were detected to profile the molecular changes in the plasma. the investigators aimed to explore the nutrient processing patterns of various macronutrients and determine the interaction between metabolic hormones and metabolites.


Eligibility criteria:
inclusion criteria: 1. those who agree to participate in the study and sign informed consent. 2. age between 20 and 65 year. 3. fasting plasma glucose \< 7.0mmol/l, and 2-hour postprandial plasma glucose \< 11.1mmol/l. 4. bmi \> 18 kg/m2. exclusion criteria: 1. history of diabetes. 2. pregnant or lactating women. 3. the subjects had not received oral/systemic corticosteroids for 7 consecutive days during the last 6 months. 4. subjects were taking medication known to affect glucose metabolism. 5. subjects who take strong inhibitors of cytochrome p450 (cyp)3a4/5, for example, ketoconazole, azanaway, clarithromycin, indinavir, itraconazole, nefazodone, nelfinavir, ritonavir, saquinavir and telithromycin. 6. patients with either of the following characteristics of severe hepatic disease: i. two consecutive abnormal hepatic function results during recent four weeks, with alt or ast three times the upper limit of the institutions normal reference ranges. ii. hepatic excretion dysfunction (eg. hyperbilirubinemia) and/or synthesis dysfunction, or other decompensated liver disease. iii. acute viral hepatitis, autoimmune hepatitis, and alcoholic hepatitis 7. patients with moderate and severe renal impairment, and end-stage renal disease (serum creatinine \> 194.5 mmol/l, or serum potassium \> 5.5 mmol/l). 8. new york heart association (nyha) functional class iii or iv congestive heart failure. 9. history of acute or chronic pancreatitis. 10. history of gastrointestinal disorders: gastroenterostomy, enterectomy, ileus and intestinal ulcers. 11. subjects with previously diagnosed malignancy within the past 5 years. 12. any other reasons that the investigator considered inappropriate to participate in the study.
a multi center study to validate a condition-specific measure of sexual health in women with pelvic floor disorders

Conditions: Pelvic Floor Disorders; Sexual Dysfunction; Incontinence; Pelvic Organ Prolapse

Summary: study aims: 1. to validate a new measure of sexual function and activity in women with pfds; 2. to establish the responsiveness to change of the new measure. the investigators hypothesis is that the investigators can create a new questionnaire that accurately measures sexual health in women with pelvic floor disorders that improves on the already published questionnaires.

600 women presenting for care to urogynecology clinics in the united states and england will be recruited to participate. they will give data regarding their physical exam, including measurements by the pelvic organ prolapse quantification exam and medical and surgical history. in addition, they will complete validated questionnaires including the incontinence severity index, the pelvic floor distress inventory (short form) and question # 35 from the epidemiology of prolapse and incontinence questionnaire. all women will also complete two sexual health questionnaires; the female sexual function index and the pelvic organ prolapse urinary incontinence sexual questionnaire (revised). women will receive standard care for their pelvic floor disorders. they will then be recontacted to repeat the same set of questionnaires to determine the responsiveness of the new measure. reliability of the questionnaire will be measured by having a subset of women complete the questionnaire twice; a factor analysis will be performed to determine the underlying factor structure. responses to the other qol measures will be compared to those to the new instrument to establish validity.

Eligibility criteria:
inclusion criteria: * inclusion criteria for patients include age over 18 years. * not pregnant. * able to read/write and understand english. * and, because this is a project to validate a measure of female sexual function, all subjects will be women. * all women will be seeking care for pfd including urinary and anal incontinence and pop. since data collection will primarily be by mail * women must have a stable and current address. exclusion criteria: * women under the age of 18. * are pregnant or who are unable to read/write or understand english will not be eligible for participation. * in addition, women with a diagnosis of vulvodynia, painful bladder syndrome, or chronic pelvic pain (defined as pelvic pain for greater than 6 months) as determined by the consenting physician will be excluded. * since this is a study to evaluate both sexual activity status as well as sexual function, women need not be sexually active to participate.

Keywords: pelvic floor disorders sexual function incontinence pelvic organ prolapse